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The Study, Conducted With 54 Individuals Over the Age of 65, Aimed to Reveal the Advantages and Disadvantages of a Combined Exercise Program Compared to Otago Exercise Alone. (OPEP-SARCOBAL)

1. juli 2026 opdateret af: Mesut Uludag, Hacettepe University

Otago Plus Proprioceptive Exercises for Sarcopenia, Frailty, Reaction Time, Balance, Falls, and Physical Performance in Geriatric Individuals

Falls are a leading cause of morbidity and mortality in older adults.

Approximately one-third of individuals over 65 years of age fall each year, and 10-15% of these falls result in serious injury.

Balance disorders, decreased muscle strength, prolonged reaction time, and decreased proprioception are key factors that increase the risk of falls.

One evidence-based intervention to reduce the risk of falls is the Otago Exercise Program, originating in New Zealand.

The program includes strength and balance exercises progressed with ankle weights and walking activities, and has been shown to significantly reduce the incidence of falls in older adults.

Proprioceptive exercises aim to stimulate the sensory system responsible for body position perception and movement control. These exercises contribute to improved balance by enhancing sensorimotor integration.

Although the literature shows positive effects of Otago and proprioceptive exercise programs separately, studies comparing the effectiveness of combining these two approaches on sarcopenia, frailty, balance, falls, reaction time, and physical performance parameters are limited.

The aim of this study is to comparatively evaluate the effects of the Otago exercise program and a program combining Otago and proprioceptive exercises on sarcopenia, frailty, reaction time, balance, falls, and physical performance in geriatric individuals.

It is expected that the findings will contribute to more effective and goal-oriented planning of exercise programs in the geriatric population.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Detaljeret beskrivelse

The proportion of the elderly population is rapidly increasing worldwide and in Türkiye. According to United Nations data, the population aged 60 and over is expected to exceed 2 billion by 2050. Turkish Statistical Institute projections also foresee that the proportion of the elderly population in our country will reach 20.8% in 2050. This demographic transformation makes the prevention and management of age-related health problems a priority from a public health perspective. Aging is accompanied by a decrease in physiological reserves, an increase in the incidence of multimorbidity, and a decline in functional capacity. One of the important clinical syndromes that stands out in this process is sarcopenia, characterized by progressive decrease in muscle mass and muscle function . Sarcopenia is strongly associated with fall risk, functional decline, frailty, and increased mortality. Fragility is defined as a state of vulnerability to stress resulting from a loss of reserves in multiple physiological systems, predisposing the elderly individual to negative health outcomes. Falls are one of the leading causes of morbidity and mortality in the elderly. Approximately one-third of individuals over 65 years of age fall each year, and 10-15% of these falls result in serious injury. Balance disorders, decreased muscle strength, prolonged reaction time, and decreased proprioception are key factors that increase the risk of falls. One evidence-based intervention to reduce the risk of falls is the Otago Exercise Program, originating in New Zealand. The program includes strength and balance exercises progressing with ankle weights and walking activities, and has been shown to significantly reduce the incidence of falls in elderly individuals. Proprioceptive exercises, on the other hand, aim to stimulate the sensory system responsible for body position perception and movement control. These exercises contribute to improved balance by enhancing sensorimotor integration. Although the literature shows positive effects of Otago and proprioceptive exercise programs separately, studies comparing the effectiveness of combining these two approaches on sarcopenia, frailty, balance, falls, reaction time, and physical performance parameters are limited. The aim of this study is to comparatively evaluate the effects of the Otago exercise program and a program combining Otago and proprioceptive exercises on sarcopenia, frailty, reaction time, balance, falls, and physical performance in geriatric individuals. The findings are expected to contribute to the more effective and goal-oriented planning of exercise programs in the geriatric population.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

54

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Altındağ
      • Ankara, Altındağ, Tyrkiet (Türkiye)
        • Hacettepe University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 65 years of age or older,
  • Able to speak and understand Turkish,
  • Have at least a primary school education,
  • Be able to respond to simple verbal commands.

Exclusion Criteria:

  • Serious musculoskeletal pathology that may affect proprioception (advanced rheumatoid arthritis, severe osteoarthritis, major joint deformity, etc.), Major neurological or systemic disease that may affect proprioception (diabetic neuropathy, Vascular insufficiency, Post-stroke hemiplegia, Parkinson's disease, Inability to respond to commands due to cognitive dysfunction (SMMT <18 points), Severe visual or hearing loss, Lower extremity amputation or having undergone major lower extremity surgery within the last year.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control Group
No exercise program was applied to the patients in this group. Only sequential measurements were taken and the results were compared with other groups.
Eksperimentel: Otago Exercise Group
Only patients in this group received the Otago Exercise Program.
There are no studies in the literature that combine proprioceptive exercises with otago exercises. In our study, we applied these combined exercises for the first time.
Eksperimentel: OTAGO EXERCISES COMBINED WITH PROPRIOCEPTIVE EXERCISES
Patients in this group received a proprioceptive exercise program in conjunction with the Otago Exercise Program.
There are no studies in the literature that combine proprioceptive exercises with otago exercises. In our study, we applied these combined exercises for the first time.
As an intervention, participants were given exercises to improve their proprioception (sense of joint position, sense of movement, etc.) in addition to the otago exercises.
Andre navne:
  • Otago Exercise Programme

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Frailty Measured by the Edmonton Frailty Scale (EFS)
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
The Edmonton Frailty Scale (EFS) assesses 9 domains (cognition, general health, functional independence, social support, medication use, nutrition, mood, continence, functional performance). Total score ranges from 0 (not frail) to 17 (very severe frailty). Assessments conducted at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Muscle Strength Measured by Hand Grip and Knee Extension Dynamometry
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
Hand grip strength measured in kilograms (kg) using a hand dynamometer. Knee extension strength measured in kilograms (kg) using a hand-held dynamometer. Assessments conducted at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Physical Performance Measured by the 4-Meter Walking Speed Test
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
Time (in seconds) to walk 4 meters at usual pace. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Muscle Mass Measured by Gastrocnemius-Soleus Circumference
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
Calf circumference measured in centimeters (cm) using a tape measure at the maximal girth of the gastrocnemius-soleus complex. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Reaction Time Measured by the Nelson Hand and Foot Reaction Test
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
Reaction time measured in milliseconds (ms) using the Nelson Hand and Foot Reaction Test. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Peripheral Sensation Measured by Semmes-Weinstein Monofilament Test
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
Monofilament filament size (log10 force in mg) at which sensation is detected on the foot. Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
From enrollment to the end of treatment at 6 weeks (18 sessions)
Change in Balance and Falls Measured by Number of Falls and Balance Testing
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
Falls recorded as total number of falls per participant over 6 weeks. Balance assessed using a validated balance scale (e.g., Berg Balance Scale or Timed Up and Go test in seconds). Assessed at baseline (week 0), interim (week 3), and final (week 6).
From enrollment to the end of treatment at 6 weeks (18 sessions)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2023

Primær færdiggørelse (Faktiske)

31. december 2025

Studieafslutning (Anslået)

6. oktober 2026

Datoer for studieregistrering

Først indsendt

20. januar 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-delingstidsramme

only IPD used in the results publication

IPD-delingsadgangskriterier

researchers

IPD-deling Understøttende informationstype

  • CSR

Studiedata/dokumenter

  1. Studieprotokol
    Oplysningskommentarer: https://etikkurul.karatekin.edu.tr/dogrulama/6f3d5fcd4f8d4a2e / https://sbetikkurul.karatekin.edu.tr/

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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